September webinars will expound on the results of the consortium’s work.
Bethesda, Md., – The Parenteral Drug Association (PDA) and BioPhorum today announced that the Sterile Filtration Quality Risk Management (SFQRM), jointly created by the two organizations, has completed its final publication to help clarify industry thinking on the implications of pre-use post-sterilization integrity testing (PUPSIT) of sterilizing filters. The work product includes two research papers and two points-to-consider technical documents.
The last document, Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT), published today (AUG 25), and is available at the PDA Bookstore www.pda.org/bookstore.
“For almost 75 years PDA has been committed to providing scientific answers to regulators' concerns. The results of this effort on PUPSIT reflects this core PDA goal and we are very excited to have reached this point in the project,” said Richard Johnson, PDA President.
"Until now industry has only had conjecture and compliance as guides to their actions in the great PUPSIT debate. With these publications we have studies, science and best practice so that rationale and common sense can be brought to bear," said Tony White, BioPhorum Director.
On September 1, members of the SFQRM will participate in the first in a series of meetings presenting the background of, reasons for, challenge to, and approach for mitigating the risk of sterilizing filtration, that has prompted the use of PUPSIT. The Sept. 1 virtual meeting is titled, The Role of PUPSIT within the Assurance in Sterilizing Filtration. The next virtual meeting will take place on Sept. 8 and is titled, Assessing the Risk of Filter Masking – Test Description and Results. And the final occurs on Sept. 21, entitled Practical Implication and Decision Making of PUPSIT. More information on these events can be found here:
In June, Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration published at the PDA Bookstore.
The SFQRM conducted research on PUPSIT to support the Points to Consider documents. It published two research papers in the PDA Journal of Pharmaceutical Science and Technology (accepted articles, May 28). The papers are titled:
- Test Process and Results of Potential Masking of Sterilizing Grade Filters https://doi.org/10.5731/pdajpst.2019.011189
- Datamining To Determine The Influence Of Fluid Properties On The Integrity Test Values https://doi.org/10.5731/pdajpst.2019.011387
These papers will appear in their final forms in the September/October 2020 issue.
For more information on the SFQRM PUPSIT effort, contact SFQRM Consortium facilitator Jannika Kremer, email: [email protected]
About the Sterile Filtration Quality Risk Management (SFQRM)
The SFQRM Consortium was formed by BioPhorum and the Parenteral Drug Association to provide objective, unbiased, scientific data to help guide informed decisions about sterile filtration control measures. It consists of more than 50 subject matter experts from 25 biopharmaceutical manufacturing companies and filter suppliers.
About PDA – Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of over 10,500 members worldwide. PDA is an ANSI accredited Standards Developing Organization. Go to https://www.pda.org/about-pda to learn more.
BioPhorum’s mission is to create environments where the global biopharmaceutical industry can connect, collaborate and accelerate its rate of progress, for the benefit of all.
Since its inception in 2004, BioPhorum has become the open and trusted environment where senior leaders of the biopharmaceutical industry come together to share and discuss the emerging trends and challenges facing their industry. Growing from an end-user group in 2008, BioPhorum now comprises over 90 manufacturers and suppliers deploying their top 3,500 leaders and subject matter experts to work in seven focused Phorums, articulating the industry’s technology roadmap, defining the supply partner practices of the future, and developing and adopting best practices in drug substance, fill finish, process development and manufacturing IT.
In each of these Phorums, BioPhorum facilitators bring leaders together to create future visions, mobilize teams of experts on the opportunities, create partnerships that enable change and provide the quickest route to implementation, so that the industry shares, learns and builds the best solutions together.